DESIGN, FORMULATION AND OPTIMIZATION OF RUTIN TRIHYDRATE EMULGEL BY RESPONSE SURFACE METHODOLOGY

Rutin trihydrate a herbal drug having abundant medicinal properties, mainly used for topical treatment of inflammation, presents a hindrance and reduced anti-inflammatory activity. It is a BCS class II drug having low oral bioavailability, poor water solubility (0.125 g/L), and low stability of rutin in aqueous alkaline medium, restricting its application in use. So, it is successfully formulated as an emulgel to improve its anti-inflammatory properties. The current study aims to design, formulate, and to optimize Rutin trihydrate emulgel to enhance its efficacy and stability. Emulgel was designed, optimized by using central composite design taking three independent variables and one dependent variable. Five responses were generated, and the optimized formulation was prepared using carbopol 934(0.8%), clove oil (12.5 ml), and span (2.32%). The emulsifying agent being Tween 20, Span 20, and preservatives used are methyl and propyl parabens. The formulation (F2) with this combination gave emulgel of yellow color, homogeneous with good consistency, possessed pH of 6.51 ± 0.04, drug content of 98.7%, a viscosity of 14, 980 cps, spreadability 13.5 gm.cm/sec and extrudability 36.2 and in-vitro drug release of 74.8%  for 8 h. Since, F2 emulgel possesses an edge in terms of spreadability, viscosity, extrusion, in-vitro drug release it would become a solution for loading hydrophobic drugs in a water-soluble gel base.